Query

A query is a query about entries in the CRF (study protocol) of a clinical study. Queries are usually made by the monitor or data manager and are used to clarify inconsistencies, incompleteness or incorrect data entries.

Queries can be made by email or directly on site at the test center. It is important that any corrections made to paper CRFs are neatly dated and signed so that the previous entry is still legible. Multiple strikethroughs or other ways of making entries unrecognisable is a violation of current guidelines and will be evaluated as finding during audits. Queries may only be answered by the study team at the trial site, e.g. the monitor may under no circumstances make changes in the CRF himself.

With eCRFs (electronic case reports), the management of queries is possible with considerably less effort: since audit trails are written in the eCRF, it is possible at any time to track who made which entry or correction and when. A further advantage is that queries in eCRFs can be made immediately after entry if the patient's documents are still available or the patient is still in the study centre, so that questions can still be clarified. In some database systems a query management is stored, which makes processing much easier. With SecuTrial® there is a traffic light system, which clearly shows the investigators, study nurses and CRAs who last asked which queries or who has already answered them.